NCT02679105已完成2 期
Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U -a Human Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Total daily symptoms and medications score
研究概览
简要总结
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
详细描述
38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55
- •Accepted and signed informed consent.
- •Recently (within 20 months) ended a full 3 year program with subcutaneous immunotherapy (SCIT) with amelioration of symptoms but not full symptom relief.
排除标准
- •Previously subcutaneous immunotherapy (SCIT) with total symptom relief.
- •Previously SCIT but no symptom improvement at all.
- •Sensitizations to house dust mite or furry animals, with symptoms.
- •Severe atopic dermatitis.
- •Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- •Patients with a respiratory tract infection in the past 4 weeks prior to Visit
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).
- •Known autoimmune or collagen disease
- •Cardiovascular disease
- •Perennial pulmonary disease including asthma
- •Hepatic disease
- •Known renal insufficiency
- •Hematologic disease
- •Chronic infectious disease
- •Any medication with a possible side-effect of interfering with the immune response
- •Previous immuno- or chemotherapy, apart from SCIT
- •Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
- •Major metabolic disease
- •Known or suspected allergy to the study product
- •Obesity with BMI > 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.
- •Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit
- •Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit
- •Mental incapability of coping with the study
- •Withdrawal of informed consent
研究组 & 干预措施
ALK diluent
Placebo Comparator
Human albumin
干预措施: ALK diluent (Drug)
ALK Alutard birch or 5-grasses
Active Comparator
Grass pollen suspension or birch pollen suspension
干预措施: ALK Alutard birch or 5-grasses (Drug)
结局指标
主要结局
Total daily symptoms and medications score
时间窗: 5-7 months after treatment
Difference between active and placebo group in total daily symptoms and medications score during the pollen season.
次要结局
- Difference between active and placebo group in Quality of Life measured with Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(Up to 7 months after treatment.)
- Improvement on Visual Analogue Scale (VAS)(During pollen season and recalled after pollen season, approximately 1 year after the start of treatment.)
- Incidence of adverse events graded as mild-moderate-severe(From first injection to 30 days after last injection.)
- Change in skin prick test reactivity(4-8 weeks after treatment, 9-12 months after treatment)
- Change in symptoms score after nasal allergen challenge(4-8 weeks after treatment, 9-12 months after treatment)
- Change in allergen specific S- antibody levels.(4-8 weeks after treatment, 9-12 months after treatment)
- Difference between active and placebo group in Quality of Life measured with Sino Nasal Outcome Test -22 (SNOT-22)(Up to 7 months after treatment.)
研究者
Lars Olaf Cardell
Professor, Head of Division, MD
Karolinska Institutet
研究点 (3)
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